FDA and ISO 13485

According to the U. S. Food and Drug Administration (FDA), it intends to harmonize and modernize the Quality System regulation for medical devices.

The FDA announcement states that the revisions will supplant the existing requirements with the specifications of an international consensus standard for medical device manufacture, ISO 13485:2016. The revisions are intended to reduce compliance and recordkeeping burdens on device manufacturers by harmonizing domestic and international requirements.

ISO 13485

ISO 13485:2016, “Medical devices – Quality management systems – Requirements for regulatory purposes”, specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g., technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.

For more information about the ISO 13495 standard, or to order it, go to this ISO web page.